title: Clinical research in India: great expectations?
abstract: India is considered as a preferred site for conducting global clinical trials. Existence of a large treatment-naïve population, availability of English-speaking, skilled doctors, plenty of clinical material, and cost-savings are obvious advantages for carrying out clinical research in India. However, challenges exist at various levels. Lack of formal training in bioethics and research methodology, heavy burden of clinical duties and sub-optimal administrative support restrict investigators. Absence of oversight of functioning of ethics committees (ECs) and lack of mechanisms for ensuring quality of ethics review heighten societal concerns about safety of participants. Conducting research on issues not relevant to local needs and failure to ensure post-trial access further enhance society's cynicism. These issues need to be tackled through capacity building, training of investigators and EC members, strengthening of EC functioning and encouraging greater community participation.
authors.affiliation: Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai, India. urmilathatte@rediffmail.com
authors.forename: U M
authors.initials: UM
authors.lastname: Thatte
authors.forename: S B
authors.initials: SB
authors.lastname: Bavdekar
mesh_terms: D035843:Biomedical Research / Q000193:education / Q000941:ethics*; D002986:Clinical Trials as Topic; D017041:Ethics Committees / Q000458:organization & administration* / Q000592:standards; D004992:Ethics, Medical / Q000193:education; D006801:Humans; D007194:India; D012107:Research Design; D012108:Research Personnel / Q000193:education* / Q000941:ethics / Q000458:organization & administration; D035842:Research Subjects; D012109:Research Support as Topic / Q000941:ethics / Q000458:organization & administration; D012449:Safety